A randomized phase 2 trial of the efficacy and safety of a novel topical povidone-iodine formulation for cancer therapy-associated paronychia Journal Article
| Authors: | Capriotti, K. D.; Anadkat, M.; Choi, J.; Kaffenberger, B.; McLellan, B.; Barone, S.; Kukoyi, O.; Goldfarb, S.; Lacouture, M. |
| Article Title: | A randomized phase 2 trial of the efficacy and safety of a novel topical povidone-iodine formulation for cancer therapy-associated paronychia |
| Abstract: | Purpose Cancer therapy-associated paronychia (CAP) is a frequent adverse event associated with cytotoxic and targeted therapies that may impact dosing of anticancer therapies and patient quality of life (QoL). There are currently no evidence-based management strategies or approved treatments for CAP. Materials and Methods This was a prospective, multicenter, randomized, double-blind, vehicle-controlled phase 2 study that evaluated the efficacy and safety of 6 to 8 weeks of 1% or 2% povidone-iodine (PVP-I) topical solution versus vehicle-control in adult patients with CAP. Patients were randomized to one of three treatment arms administered twice daily: 1% PVP-I (Cohort A), 2% PVP-I (Cohort B), or vehicle-control (Cohort C). The primary endpoint was a two-grade reduction (or reduction to grade 0 if involved nails were grade 1) on the six-point Paronychia Severity Grading (PSG) scale. Secondary endpoints included safety and the effect on QoL and microbiota. Results A total of 102 patients with cancer were randomized to the study. In Cohort A, 83 of 205 (40.5%, P = 0.6059) affected nails met the primary endpoint versus Cohort C. In Cohort B, 88 of 167 (52.7%, P = 0.0063) affected nails met the primary endpoint versus 64 of 169 (37.9%) in Cohort C. Nineteen of 29 patients (65.5%) in Cohort B reported moderately or very painful nails at baseline that decreased to 15 patients (51.7%) at visit 2 and five patients (17.2%) at visit 3. Conclusions Treatment with twice-daily topical 2% PVP-I was safe and resulted in improvement in CAP compared with control. Clinicaltrials.gov identifier: NCT03207906. https://clinicaltrials.gov/ct2/show/NCT03207906. © 2019, Springer Science+Business Media, LLC, part of Springer Nature. |
| Keywords: | adult; controlled study; treatment response; major clinical study; drug efficacy; drug safety; pancreas cancer; prospective study; quality of life; infection; phase 2 clinical trial; sensory neuropathy; breast cancer; randomized controlled trial; peripheral neuropathy; cohort analysis; lung cancer; cancer therapy; abdominal pain; asthenia; nail disease; pneumonia; prostate cancer; rash; disease severity; multicenter study; colon cancer; lymphoma; urinary tract infection; peripheral edema; erythema; oropharynx cancer; skin disease; toxicity; mammalian target of rapamycin inhibitor; double blind procedure; bacterium culture; povidone iodine; rectum cancer; neurologic disease; pain assessment; gastrointestinal disease; injury; epidermal growth factor receptor kinase inhibitor; respiratory tract disease; dysgeusia; paronychia; xerosis; female genital tract cancer; antimicrobial activity; skin pain; microflora; mitogen activated protein kinase kinase inhibitor; fungal cell culture; application site pain; anticancer; application site irritation; povidone-iodine; onychomadesis; spine fracture; human; male; female; priority journal; article; disease severity assessment; throat irritation; paronychia severity grading scale; peripheral sensory neuropathy |
| Journal Title: | Investigational New Drugs |
| Volume: | 37 |
| Issue: | 6 |
| ISSN: | 0167-6997 |
| Publisher: | Springer |
| Date Published: | 2019-12-01 |
| Start Page: | 1247 |
| End Page: | 1256 |
| Language: | English |
| DOI: | 10.1007/s10637-019-00825-0 |
| PUBMED: | 31240513 |
| PROVIDER: | scopus |
| PMCID: | PMC7484976 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
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